Download - Minividas Immunoassay System Manual 2
mini VIDAS Essentials-Version 001-15
Essentials
mini VIDAS Essentials-Version 001-15 2
Table of Contents
Main Menu 3
System Overview 3
Sample Handling 4Pre-analytical step
Calibration 5
MLE Card 6
Calibration 7
Sample Identification 9from Status Screen
Run Samples 10
Result interpretation 11
Trouble Shooting 12 - 13
Package Insert 14
Maintenance 15 - 17
How to use a Pipette : 18Patient Sample
How to use a Pipette : Standard 19& Control Reconstitution
How to calculate centrifugation 20speed
TPSA 21 - 24
miniVIDAS Description PAGE
Routine Use PAGE
More on miniVIDAS PAGE
TPSA on mini VIDAS PAGE
Pipetting and Centrifugation PAGE
Protocol Update 8
mini VIDAS Essentials-Version 001-15 3
1
2
3
4
5
6
Sample External Barcode reader
Integrated PC with Touch Pad
Strip loading (12 positions)
SPR loading position
Integrated Thermal Printer
1
2
3
4
5
6SPR block LedLed off : Available section. Led on (green) : Section in use
Touch Pad : key functions
1
2
3
4
5
To start an analysis as soon as SPR, strips and samples are in position.
To know the status of sections A & B and temperature of SPR and Strip areas.
To read the Master Lot card for any new parameter or new assay lot.
Direct access to stored results for validation, print or reprint of assay list .
Configuration of the instrument (e.g: unit, date & time, user ID, language, printer, barcode wand).
Main MenuInstrum
ent useInstrum
ent useSystem Overview
Utility Menu 5
Start Section 1
Status Screen 2
Master Lot Menu 3
Result Menu 4
To erase a data entry
To go back to the previous screen
Press once : it will display errorsPress twice : to print out the screen
The "ENTER" key to validate data
To move the cursor on certain screensTo show a 2nd or 3rd screen
mini VIDAS Essentials-Version 001-15 4
The pre-analytical step is essential when performing medical analyses. In conformity with Good Laboratory Practices, this step is the responsibility of the Laboratory Manager even if sample collection is delocalized.
The presence of fibrin or suspended particles may lead to erroneous results, even when heparinized sample tubes are used. This fibrin can sometimes be in micro-clot format and invisible to the naked eye.
• Use the correct sample volume to ensure optimal blood/additive ratio.
• Homogenize the tube as soon as the sample has been collected by slowly turning it upside down.
• The air bubble must move from one end of the tube to the other.
• It is important to turn the tube upside down for the required number of turns (from 4 to10 depending on the tube reference)
Clot formation and retraction time• Respect the recommended time.• It is the responsibility of each laboratory
to validate the type of sample tube used and to follow the manufacturer’s recommendations for use.
• Maintain the tubes vertically throughout the coagulation phase.
Follow the centrifugation conditions of speed, duration and temperature.
The WHO recommendations are :• Serum: at least 1500g for 10 min.• Plasma: at least 2500g for 10 min.• Temperature : < 30°C.
All frozen tubes as well as tubes which have been shaken or withresuspended constituents after centrifugation, must be recentrifuged before starting the analysis (risk of interference with results or needle clogging)
How to calculate the centrifugation speedin rpm or g ?
The size of the rotor and operational speed (RPM) determines the RCF (xg).
More information on
Page
And on the web site :
www.djblabcare.co.uk
21
How to handle samples Pre-analytical stepInstrum
ent use Instrum
ent use
mini VIDAS Essentials-Version 001-15 5
Is it a new lot ?
NO YES
See
See
• When to calibrate ?• When opening a new kit or new lot.• Every 14 or 28 days (dependent on the parameter – see package insert).
• How to know if a new calibration is needed?
• The mini VIDAS will give you a message.• Check in the Calibration Menu.
• Technical points to respect • Type of diluent for Standard &
Control reconstitution.• Volume of reconstitution.• Let stabilize (see time in the
specific package insert).• Proper mixing before pipetting in
the strip.• Proper storage after reconstitution.• Never mix kit components from
different kits or lots.
Refer to the package insert of each test.
If control values are out of the expected range, results
can not be validated !
6
7
How to perform a calibrationInstrum
ent use Instrum
ent use
1 – Read the MLE card
2 – Run Standards (S)
& Controls (C)
In case of a new parameter :
Update the assay protocol See 8
17
Every 14 days or 28 days
(depending on parameters)
mini VIDAS Essentials-Version 001-15 6
Insert MLE card in the card-holder
Put the card in the direction of the arrow in the card holder.
How to read an MLE card
Insert the card holder into an available section
Read MLE card
Check MLE card and printed data correspondence
At the end of the reading :
the MLE card is automatically printed.
the screen returns to the MasterLot Menu.
=
Be sure to insert the plastic holder inside the grooves of the section.
DO NOT fold the MLE card
Instrument use
Instrument use
1
2
3
4
up
down
Start Section
Status Screen
Master Lot Menu
Results Menu
Utility Menu
B
A Available
Display temperatures
Available
mini VIDAS Essentials-Version 001-15 7
Start
Section B1
2
3
4
5
6
HCG
HCG
HCG
HCG
HCG
S1
S1
C1
100
951201001 GP
951201043 MD
100
Prepare Status ScreenStart Section
Status Screen
Master Lot Menu
Results Menu
Utility Menu
B
A Available
Display temperatures
Available
SPosition B1
C
Assay
Dilution
Sample ID
Enter Standardnumber (1-9)
Standards
Controls
S1 (X 2 or 3)
(refer to package insert)
1
2
C1 or C1+C2(+C3)(refer to package insert)
Load the reagents and samples
Run the analysis
Interpret the results
Start
Section B1
2
3
4
5
6
HCG
HCG
HCG
HCG
HCG
S1
S1
C1
100
951201001 GP
951201043 MD
100
1 - Load SPR 1st
2 - Load Strips
Example of a « Load Help Screen »
• Check correspondence of color dots.
See p
If control values are out of the
expected range, results cannot be
validated.
• Always start by preparing the status screen before loading reagents.
• The number of Standards and Controls needed will depend on the assay.
Always refer to the package insert.
• Volume to pipette depends on the reagent:
Refer to package insert.
• Mix S and C before pipeting.
Remove reagents from the fridge
11
+2–8°C
S1
C1
How to run the Standards (S) and Controls (C) for calibrationInstrum
ent use Instrum
ent use
- ONLY remove the necessary number of tests from kit box- Return the remaining kit materials to 2 –8°C- Leave tests sit 30 min at room temperature before use
or
1
1
2
3
4
5
3 – Pipette the Standard(s) and Controls
1
Type positionnumbers on key board
SPosition B3
C
Assay
Dilution
Sample ID
Enter Controlnumber (1-3)
Start
Section B123
4
5
6
Start
Section B12
3
4
5
6
mini VIDAS Essentials-Version 001-15 8
How to update a protocol
At the end of the reading :
The Assay Update Report will automatically print.
Respect the reading order.
Instrument use
Instrument use
1
2
3
Start Section
Status Screen
Master Lot Menu
Results Menu
Utility Menu
See the protocol barcode
Package insert
On last page:
Open the package insert
Read the barcode
Read the barcode
1
CautionAlways read the protocol barcode before reading the MLE card
> 5 cm
Up and down scan
+ BIPGreen LED = reading complete
mini VIDAS Essentials-Version 001-15 9
Start Section
Status Screen
Master Lot Menu
Results Menu
Utility Menu
B
A Available
Display temperatures
Available
Start
Section B12
3
4
5
6
• Always start by preparing the status screen before loading reagents.
For each sample position :
Type positionnumbers on key board.
Enter Sample IDby selecting letters
with the arrow keys and/or numbers with the key pad.
• 12 numeric characters maximum.
• Press the arrow keys to select the appropriate character.
SPosition B3
C
Assay
Dilution
Sample ID
951201001 GP
HCG
1:100
SPosition B1
C
Assay
Dilution
Sample ID
SPosition B3
C
Assay
Dilution
Sample ID
In case of dilution :Only for quantitative tests.
SPosition B3
C
Test
Dilution
ID échantillon
951201001 GP
CEA
ClrDilution
Min: 1Max: 999
100 SPosition B3
C
Assay
Dilution
Sample ID
951201001 GP
CEA
1:100
Load Help screenAfter identification of all samples :
How to identify samples in the status screenInstrum
ent use Instrum
ent use
1
A4 IDClr
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
95
951201001 GP
VAN
- . / # ! + : ( )
Position B3
Start
Section B12
3
4
5
6
ANNA
951201043 GP
LEO
992346981 SH
mini VIDAS Essentials-Version 001-15 10
Prepare Status Screen
Load reagents and samples
Run the analysis
Interpret results
1 - Load SPR 1st
2 - Load Strips
Example of a « Load Help Screen »• Check correspondence
of color dots.
See p If controls values are out of the expected range, results cannot be validated.
• Always start by preparing the status screen before loading reagents.
• Volume to pipette depends on the reagent
see package insert.
See p
Is there a valid calibration ?
Yes NoCreate calibration first
See pRemove reagents from fridge
- ONLY remove the necessary number of tests from kit box.- Return the remaining kit reagents to 2 –8°C.- Allow necessary reagents to sit 30 min at room temperature
before use.
7
9
11
+2–8°C
How to run samplesInstrum
ent use Instrum
ent use 1
2
3
4
5
3 - Pipette sample
Start
Section A12
3
4
5
6
HCGHCG
HCG
HCG
HCG
S1S1
C1
100
951201001 GP
951201043 MD
100 992346981 SH
Start
Section A12
3
4
5
6
HCGHCG
HCG
HCG
HCG
S1S1
C1
100
951201001 GP
951201043 MD
100 992346981 SH
mini VIDAS Essentials-Version 001-15 11
m i n i Vidas Report
Ferritin (FER)
Section : A Completed: 15:14:29 18Jul08Tech: OLGAFerritin (FER)Ver: R5.3.0Lot#: 090204-0
Standard used:Completed: 15:14:29 18Jul08RFV = 4034
Position :B1 Standard 1Background: 166 RFV: 4034
Note: Std. run in singlicate.~ - Low control.# - Low RFV.d - Sample over-diluted.
Position :B2 Standard 1Background: 158 RFV: -1#
Position :B3 Control 1Background: 163 RFV: -3Result: < 1,50 ng/ml ~Position :B4Sample ID: 123456Background: 158 RFV: 10280Result: > 1200 ng/mlPosition :B5Sample ID: 741852Background: 161 RFV: 240Result: 2243.05 ng/mlDilution: 1:100
Position :B6Sample ID: 456789Background: 159 RFV: 2Result: INVALID dDilution: 1:100
BIOMERIEUX
Completed: 16:07:49 07jan09Tech : TOM
mini Vidas Report
Toxo IgM (TXM)
Section : A BIOMERIEUX
Ver: R5.3.0Lot#: 090225-0
Standard used:Completed: 10:57:23 02jan09RFV =3396
Position : A2Sample ID: 990412Background: 105 RFV:94VT:0.02 Result:Negative
TV Negative < 0.55TV Equivocal >= 0.55 to < 0.65TV Positive >= 0.65
Position : A1Sample ID: 12345Background: 101 RFV:3496TV:1.02 Result:Positive
Potential ErrorMessages
Patient Results
Cslibration Information
Date of completion
Qualitative test Quantitative testGives an interpretation of
positive, negative or equivocal
Gives a quantity
How to interpret resultsInstrum
ent use Instrum
ent use
Kit lot number
Interpretation of qualitative test
mini VIDAS Essentials-Version 001-15 12
Troubleshooting 1/2
Bad MLE data1. Check the Mini-VIDAS version (must be the latest version). 2. Check the good position of the MLE card and repeat automatic reading. 3. If still MLE data bad: enter the MLE card barcodes manually:
Errorcode: 2073Time: 16:48:56 29Jun95
Master lot data bad
+ BipMaster Lot
clr6 / 16
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z +
Prev.
Bad• Clear “bad”
Numbers lettersØ ≠ O1 ≠ I
Bad barcode
Issues Solutions
• Enter manually the 8 alphanumeric digit barcode (on the strip) with the key pad.
• Press twice,and select “Restart”.
Press to stop any alarmand access the Solutions’ menu.
?
Substrate error1. Check the last cuvette on the strip and restart2. If the error persists: do not use this strip use a new strip
For assistance please call bioMérieux
Technical Support.
Instrument use
Instrument use
1
2
3Section A ErrorHBST Sub (506)1
23
Section A Error
HIV
Bad barcode
Empty
Bad barcode
EmptyEmpty
123456
OK
• Enter code of the correspondingline (code on MLE card).
• Go backautomatic printing of MLE
card.
Master Lot
clr6 / 16
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z +
Prev.
Select the number of the position with error.
1
ClrA1 BC
S T U V W X Y Z
A B C D E F G H I
- . / # ! + : < >
J K L M N O P Q R
ClrA1 BC
S T U V W X Y Z
A B C D E F G H I
- . / # ! + : < >
J K L M N O P Q R
mini VIDAS Essentials-Version 001-15 13
Calibration error
For assistance please call bioMérieux
Technical Support.
Troubleshooting 2/2
Section A Error123
4
56
HCG No Master Lot
Empty
HCGHCGHCG
HCG
No Master LotNo Master LotNo Master Lot
No Master Lot
Section A ErrorHCGHCG
EmptyEmpty
HCGHCG
Old standardOld standardOld standardOld standard
123456
Section A ErrorHCGHCG
EmptyEmpty
HCGHCG
No StandardNo StandardNo StandardNo Standard
123456
No existing calibration,
or
No identified position for standard in the status Screen
Expired standard
No Master Lot Data for the assay
Read the MLE card : See p 6
Perform a new calibration
Perform a calibration
Check and identify position for standard See p 7
Issues Solutions Press to stop an alarm and to access the Solutions’ menu.
?
5
Kit expired use a new lot
Lot error 4Section A Error
HBST Lot expired)123
Instrument use
Instrument use
mini VIDAS Essentials-Version 001-15 14
Questions? The answer is in the package insert !
Page 1
• How to reconstitute and store Standards and Controls ? • How many Standards and Controls to run? • Which volume to pipette?
Page 3
• S1 X 2 or 3 ?• C1 or C1 + C2 +C3
• What is this test used for? • Which sample type is used ?Page 1
Page 3
Intended use
ProcedureKit description
Instrument use
Instrument use
Sample collection
mini VIDAS Essentials-Version 001-15 15
1
Screwdriver Dacron swab(Part no. 30 531)
bleach solution(0.5-0.6% active
chlorine)
Small sponge cubes& curved forceps
Freshdistilled water
WEEKLY:Cleaning of the SPR blocks.
Fullu openthe section door.
Dacron swab + detergent solution
Clean the interior of each SPR sleeve.
Dacron swab + distilled water
Rinse each SPR sleeve.
curved forceps + sponge + detergent
Swab the rear of the SPR block pushing each SPR sleeve.
mini VIDAS « Grey » mini VIDAS « blue »
Remove the 2 screws
Open the strip’s preparation
tray by tilting it forward.
sponge + detergent solution
clean the 6 channels.
Repeat with a new sponge + bleach solution.
Sponge + distilled water.
Rinse each tray.
Raise the strip preparation tray and screw the 2 screws back into place.
MONTHLY:Cleaning of the reagent strip trays(similar procedure for underneath plastic tray).
Required material to do the maintenance.
H2OBleach
Solution
Powderless gloves
For assistance please call bioMérieux
Technical Support.
10
10
2 3
1 2 3
Detergentsolution
Detergent solution
Instrument use
Instrument use
How to perform maintenance 1/3
Leave for
Leave for
• Instrument must be turned off.
Refer to user’s manual for detailed data.
mini VIDAS Essentials-Version 001-15 16
MONTHLY:Cleaning the 2optical lenses.
Required material to do the maintenance.
How to perform maintenance 2/3Instrum
ent use Instrum
ent use
For assistance please call bioMérieux
Technical Support.
VIDAS Lens cleanerreference 93567
With the pump, blow air on the 2 optical lenses.
optical lens
• Instrument must be turned off.
mini VIDAS Essentials-Version 001-15 17
3
1MONTHLY:Performing VIDAS QCV test.
Required material to do the maintenance.
2
Instrument use
Instrument use
For assistance please call bioMérieux
Technical Support.
VIDAS QCVreference 30706
QCV test must be run in EVERY position
How to interpret the QCV test :
Acceptable range for R3 :Each position must be
≥ 4100 RFU
check the R3 value
Acceptable range for TV1 : Each position must be ≥ TV1 valuewritten on the VIDAS® QCV kit label.
check the TV1 value
Code QCV
Run duration
20Start
Section A12
3
4
5
6
HCGHCG
HCG
HCG
HCG
S1S1
C1
100
951201001 GP
951201043 MD
100
No position identification required.
In case of out of range results :For TV1 :VIDAS® QCV strips must be re tested twice successively in each position.
If 2 out of 3 TV1 values for the same position are out of range, the position is defective.
PUT THE SECTION OFFLINE and Call bioMérieux Technical Support
For R3 : An system anomaly is suspected if at least one position produces a value for R3 < 4100 RFU.
PUT THE SECTION OFFLINE and Call bioMérieux Technical Support
TV1 xxxx
How to perform maintenance 3/3
mini VIDAS Essentials-Version 001-15 18
Use a fixed volume pipette or set the correct volume (following manufacturer’s instructions.)
Put the tip inplace.
Note : Change the tip with each
new sample.
1 - Preparation:
Depress to the1st stop position.
2 - Aspiration
Dip the tip into the sample. Allow the plunger to smoothly return to the restposition.
4 - Home
A- Return to therest position.
B- Dispose of the tip.
A B
3 - Dispense
- Pipette sample into the sample well (1st
well) by smoothly depressing to the 2nd
stop.
How to use a pipette: patient sample
A - Prepare B - Aspirate C- Dispense
Position:• Rest• 1st stop• 2nd stop
1st well
Instrument use
Instrument use
mini VIDAS Essentials-Version 001-15 19
2 – AspirationDip the tip into thediluent or water. Allow the plunger tosmoothly return tothe rest position.
B - Aspirate1- PreparationDepress to the1st stop position.
4- HomeA- Return to the
rest position.B- Dispose of the tip.
A B
C- Dispense3- DispensePipette diluent/water into the vial by smoothly depressing to the 2nd
stop.
How to use a pipette: Standard & Control reconstitutionInstrum
ent use Instrum
ent use
Note : Dependant on the assay,distilled water may be replaced by a specific diluent. REFER to the package insert.
Position:• Rest• 1st stop• 2nd stop
Note : Use the same procedure for control(s).
S1
Use a fixed volume pipette or set the correct volume (following manufacturer’s instructions.)
Put the Tip inplace.
Note : Change the tip with each
new sample.
A - Prepare
mini VIDAS Essentials-Version 001-15 20
How to calculate centrifugation speed
The size of the rotor and operational speed (RPM)
determines the RCF (x g).
Use the Nomograph to calculate the speed in rpm or g.
How to calculate the centrifugation speed in rpm or in g
More information on : www.djblabcare.co.uk
Instrument use
Instrument use
mini VIDAS Essentials-Version 001-15 21
PSA (Prostate Specific Antigen) is a protein produced by the cells of the prostate and secreted in the seminal fluid. PSA liquefies seminal fluid thereby increasing sperm mobility.
PSA is present in blood with 3 main forms:
PSAACT
MG
WHAT IS TPSA ?
Free PSAPSA-ACT
PSA-α2MG(not detectable)
Total PSA (TPSA)
WHY IS TPSA TESTED ?Healthy men have low levels of TPSA. However, TPSA levels rise in prostatic pathologies such as Benign prostatichyperplasia (BPH) or prostate cancer.
The VIDAS® TPSA test measures the level of Total PSA in blood.
Determination of TPSA levels is an AID in:
the detection of prostate cancer in conjunction with digital rectal examination (DRE) in men ≥ 50 years old. Prostate biopsy is required for diagnosis of prostate cancer.
the management of prostate cancer patientsto help determine effectiveness of prostate cancer treatment and to detect disease recurrence.
PSAPSA
Tumor M
arkers : VIDA
S TPSATum
or Markers : VID
AS TPSA
TPSA
mini VIDAS Essentials-Version 001-15 22
Mix
Preparation Before use Storage
VIDAS TPSA: Reagent & Sample preparation
1500 g
Serum
Sample Type
Reagent handling
-25 ± 6°C
+2–8°C
• Only remove the required strips and SPRs.• Tightly close the SPR Bag immediately after use.• Return the kit to the refrigerator ASAP.
+2–8°C
Reagentreconstitution
S1
C1
Standard
Control
Freshdistilled water
H2O
S1
C1
30-25 ± 6°C
if > 24h
24 h
Preparation Storage
2 ml(2000 µl)
2 ml(2000 µl)
Let stand atRoom temperature.
Serum only Tumor M
arkers : VIDA
S TPSATum
or Markers : VID
AS TPSA
18°C
25°C
mini VIDAS Essentials-Version 001-15 23
MixPrepare Status Screen (See page )
+2–8°C
VIDAS TPSA : Work Sheet
• Close SPR bag.
• Put the kit in the fridge ASAP.
• One Strip/SPR per sample, standard, control.
Load reagents and samples, following Status Screen (see page )
Remove reagents from the fridge
C1S1 +
-25 ± 6°C
30C1
S1
1 - Load SPR 1st2 - Load Strips
9
Pipette into the strips then start the analysis
Start
Section A12
3
4
5
6
HCGHCG
HCG
HCG
HCG
S1S1
C1
100
951201001 GP
951201043 MD
100
Code TPSA
Run duration
60
9
S1
C1
200 µl
X2
If Calibration is required :
Protocol compatibility TPSA, CEAS, 19-9, 125, FPSA
Let standRoom temperature.
Tumor M
arkers : VIDA
S TPSATum
or Markers : VID
AS TPSA
18°C
25°C1
2
3
4
• Frozen samples must be mixed after thawing.
mini VIDAS Essentials-Version 001-15 24
Master Lot Data Entry
Lot Number _______________
Data Entry Date _______________
Calibration : S1 & C1
Date of 1st calibration _________________
Recalibration date _________________
Recalibration date _________________
Recalibration date _________________
Recalibration date _________________
A new calibration must be done:1. When a NEW lot is used.2. Every 14 days.
C1
S1
54321Only 5 Freeze/Thaw cycles are possible:
C1S1 and
-25 ± 6°C
2009
Freeze Thaw
Calibration frequency
A calibration must be done:1.When a NEW lot is used.2.Every 14 days*.
Maximum 5 times
Freeze and thaw
VIDAS TPSA: Calibration guidance VIDAS TPSA: Log sheetTum
or Markers : VID
AS TPSA
Tumor M
arkers : VIDA
S TPSA
Room temperature
18°C
25°C
mini VIDAS Essentials-Version 001-15 25
bioMérieux, the blue logo and mini VIDAS are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of itssubsidiaries.
Disclaimer :This Easy Starter is a support containing short information of mini VIDAS system and reagent use.Please refer to the instrument’s instruction manual and to the specific reagent’s package insert for more details.